FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH ZU
MDR report key: 2456019
·
Received January 25, 2012
Report
- Report Number
- 1831750-2012-00732
- Event Type
- Malfunction
- Date Received
- January 25, 2012
- Date of Event
- January 4, 2012
- Report Date
- January 4, 2012
- Manufacturer
- FLEXTRONICS EMS CANADA
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
LOCKING MECHANISM ON CASTER SHAFT.
Description of Event or Problem · 1
IT WAS REPORTED BY SERVICE REPORT THAT THE BRAKES WERE NOT HOLDING. NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IN TOUCH ZU | A/C HOSPITAL BED | FNL | FLEXTRONICS EMS CANADA | 2141 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |